The New England Journal of Medicine -- May 18, 2000 -- Vol. 342, No. 20


Is Academic Medicine for Sale?


by Marcia Angell, M.D.


In 1984 the Journal became the first of the major medical journals to
require authors of original research articles to disclose any financial
ties with companies that make products discussed in papers submitted to
us. (1) We were aware that such ties were becoming fairly common, and we
thought it reasonable to disclose them to readers. Although we came to
this issue early, no one could have foreseen at the time just how
ubiquitous and manifold such financial associations would become. The
article by Keller et al. (2) in this issue of the Journal provides a
striking example. The authors' ties with companies that make
antidepressant drugs were so extensive that it would have used too much
space to disclose them fully in the Journal. We decided merely to
summarize them and to provide the details on our Web site.


Finding an editorialist to write about the article presented another
problem. Our conflict-of-interest policy for editorialists, established
in 1990, (3) is stricter than that for authors of original research
papers. Since editorialists do not provide data, but instead selectively
review the literature and offer their judgments, we require that they
have no important financial ties to companies that make products related
to the issues they discuss. We do not believe disclosure is enough to
deal with the problem of possible bias. This policy is analogous to the
requirement that judges recuse themselves from hearing cases if they
have financial ties to a litigant. Just as a judge's disclosure would
not be sufficiently reassuring to the other side in a court case, so we
believe that a policy of caveat emptor is not enough for readers who
depend on the opinion of editorialists.


But as we spoke with research psychiatrists about writing an editorial
on the treatment of depression, we found very few who did not have
financial ties to drug companies that make antidepressants.
(Fortunately, Dr. Jan Scott, who is eminently qualified to write the
editorial, (4) met our standards with respect to conflicts of interest.)
The problem is by no means unique to psychiatry. We routinely encounter
similar difficulties in finding editorialists in other specialties,
particularly those that involve the heavy use of expensive drugs and
devices.


In this editorial, I wish to discuss the extent to which academic
medicine has become intertwined with the pharmaceutical and
biotechnology industries, and the benefits and risks of this state of
affairs. Bodenheimer, in his Health Policy Report elsewhere in this
issue of the Journal, (5) provides a detailed view of an overlapping
issue -- the relations between clinical investigators and the
pharmaceutical industry.


The ties between clinical researchers and industry include not only
grant support, but also a host of other financial arrangements.
Researchers serve as consultants to companies whose products they are
studying, join advisory boards and speakers' bureaus, enter into patent
and royalty arrangements, agree to be the listed authors of articles
ghostwritten by interested companies, promote drugs and devices at
company-sponsored symposiums, and allow themselves to be plied with
expensive gifts and trips to luxurious settings. Many also have equity
interest in the companies.


Although most medical schools have guidelines to regulate financial ties
between their faculty members and industry, the rules are generally
quite relaxed and are likely to become even more so. For some years,
Harvard Medical School prided itself on having unusually strict
guidelines. For example, Harvard has prohibited researchers from having
more than $20,000 worth of stock in companies whose products they are
studying. (6) But now the medical school is in the process of softening
its guidelines. Those reviewing the Harvard policy claim that the
guidelines need to be modified to prevent the loss of star faculty
members to other schools. The executive dean for academic programs was
reported to say, "I'm not sure what will come of the proposal. But the
impetus is to make sure our faculty has reasonable opportunities." (7)


Academic medical institutions are themselves growing increasingly
beholden to industry. How can they justify rigorous conflict-of-interest
policies for individual researchers when their own ties are so
extensive? Some academic institutions have entered into partnerships
with drug companies to set up research centers and teaching programs in
which students and faculty members essentially carry out industry
research. Both sides see great benefit in this arrangement. For
financially struggling medical centers, it means cash. For the companies
that make the drugs and devices, it means access to research talent, as
well as affiliation with a prestigious "brand." The time-honored custom
of drug companies' gaining entry into teaching hospitals by bestowing
small gifts on house officers has reached new levels of munificence.
Trainees now receive free meals and other substantial favors from drug
companies virtually daily, and they are often invited to opulent dinners
and other quasi-social events to hear lectures on various medical
topics. All of this is done with the acquiescence of the teaching
hospitals.


What is the justification for this large-scale breaching of the
boundaries between academic medicine and for-profit industry? Two
reasons are usually offered, one emphasized more than the other. The
first is that ties to industry are necessary to facilitate technology
transfer -- that is, the movement of new drugs and devices from the
laboratory to the marketplace. The term "technology transfer" entered
the lexicon in 1980, with the passage of federal legislation, called the
Bayh-Dole Act, (8) that encouraged academic institutions supported by
federal grants to patent and license new products developed by their
faculty members and to share royalties with the researchers. The Bayh-
Dole Act is now frequently invoked to justify the ubiquitous ties
between academia and industry. It is argued that the more contacts there
are between academia and industry, the better it is for clinical
medicine; the fact that money changes hands is considered merely the way
of the world.


A second rationale, less often invoked explicitly, is simply that
academic medical centers need the money. Many of the most prestigious
institutions in the country are bleeding red ink as a result of the
reductions in Medicare reimbursements contained in the 1997 Balanced
Budget Act and the hard bargaining of other third-party payers to keep
hospital costs down. Deals with drug companies can help make up for the
shortfall, so that academic medical centers can continue to carry out
their crucial missions of education, research, and the provision of
clinical care for the sickest and neediest. Under the circumstances, it
is not surprising that institutions feel justified in accepting help
from any source.


I believe the claim that extensive ties between academic researchers and
industry are necessary for technology transfer is greatly exaggerated,
particularly with regard to clinical research. There may be some merit
to the claim for basic research, but in most clinical research,
including clinical trials, the "technology" is essentially already
developed. Researchers are simply testing it. Furthermore, whether
financial arrangements facilitate technology transfer depends crucially
on what those arrangements are. Certainly grant support is constructive,
if administered properly. But it is highly doubtful whether many of the
other financial arrangements facilitate technology transfer or confer
any other social benefit. For example, there is no conceivable social
benefit in researchers' having equity interest in companies whose
products they are studying. Traveling around the world to appear at
industry-sponsored symposiums has much more to do with marketing than
with technology transfer. Consulting arrangements may be more likely to
further the development of useful products, but even this is arguable.
Industry may ask clinical researchers to become consultants more to
obtain their goodwill than to benefit from their expertise. The goodwill
of academic researchers is a very valuable commodity for drug and device
manufacturers. Finally, it is by no means necessary for technology
transfer that researchers be personally rewarded. One could imagine a
different system for accomplishing the same purpose. For example, income
from consulting might go to a pool earmarked to support research or any
other mission of the medical center.


What is wrong with the current situation? Why shouldn't clinical
researchers have close ties to industry? One obvious concern is that
these ties will bias research, both the kind of work that is done and
the way it is reported. Researchers might undertake studies on the basis
of whether they can get industry funding, not whether the studies are
scientifically important. That would mean more research on drugs and
devices and less designed to gain insights into the causes and
mechanisms of disease. It would also skew research toward finding
trivial differences between drugs, because those differences can be
exploited for marketing. Of even greater concern is the possibility that
financial ties may influence the outcome of research studies.


As summarized by Bodenheimer, (5) there is now considerable evidence
that researchers with ties to drug companies are indeed more likely to
report results that are favorable to the products of those companies
than researchers without such ties. That does not conclusively prove
that researchers are influenced by their financial ties to industry.
Conceivably, drug companies seek out researchers who happen to be
getting positive results. But I believe bias is the most likely
explanation, and in either case, it is clear that the more enthusiastic
researchers are, the more assured they can be of industry funding.


Many researchers profess that they are outraged by the very notion that
their financial ties to industry could affect their work. They insist
that, as scientists, they can remain objective, no matter what the
blandishments. In short, they cannot be bought. What is at issue is not
whether researchers can be "bought," in the sense of a quid pro quo. It
is that close and remunerative collaboration with a company naturally
creates goodwill on the part of researchers and the hope that the
largesse will continue. This attitude can subtly influence scientific
judgment in ways that may be difficult to discern. Can we really believe
that clinical researchers are more immune to self-interest than other
people?


When the boundaries between industry and academic medicine become as
blurred as they now are, the business goals of industry influence the
mission of the medical schools in multiple ways. In terms of education,
medical students and house officers, under the constant tutelage of
industry representatives, learn to rely on drugs and devices more than
they probably should. As the critics of medicine so often charge, young
physicians learn that for every problem, there is a pill (and a drug
company representative to explain it). They also become accustomed to
receiving gifts and favors from an industry that uses these courtesies
to influence their continuing education. The academic medical centers,
in allowing themselves to become research outposts for industry,
contribute to the overemphasis on drugs and devices. Finally, there is
the issue of conflicts of commitment. Faculty members who do extensive
work for industry may be distracted from their commitment to the
school's educational mission.


All of this is not to gainsay the importance of the spectacular advances
in therapy and diagnosis made possible by new drugs and devices. Nor is
it to deny the value of cooperation between academia and industry. But
that cooperation should be at arm's length, with both sides maintaining
their own standards and ethical norms. The incentives of the marketplace
should not become woven into the fabric of academic medicine. We need to
remember that for-profit businesses are pledged to increase the value of
their investors' stock. That is a very different goal from the mission
of medical schools.


What needs to be done -- or undone? Softening its conflict-of-interest
guidelines is exactly the wrong thing for Harvard Medical School to do.
Instead, it should seek to encourage other institutions to adopt
stronger ones. If there were general agreement among the major medical
schools on uniform and rigorous rules, the concern about losing faculty
to more lax schools -- and the consequent race to the bottom -- would
end. Certain financial ties should be prohibited altogether, including
equity interest and many of the writing and speaking arrangements. Rules
regarding conflicts of commitment should also be enforced. It is
difficult to believe that full-time faculty members can generate outside
income greater than their salaries without shortchanging their
institutions and students.


As Rothman urges, teaching hospitals should forbid drug-company
representatives from coming into the hospital to promote their wares and
offer gifts to students and house officers. (9) House officers should
buy their own pizza, and hospitals should pay them enough to do so. To
the argument that these gifts are too inconsequential to constitute
bribes, the answer is that the drug companies are not engaging in
charity. These gifts are intended to buy the goodwill of young
physicians with long prescribing lives ahead of them. Similarly,
academic medical centers should be wary of partnerships in which they
make available their precious resources of talent and prestige to carry
out research that serves primarily the interests of the companies. That
is ultimately a Faustian bargain.


It is well to remember that the costs of the industry-sponsored trips,
meals, gifts, conferences, and symposiums and the honorariums,
consulting fees, and research grants are simply added to the prices of
drugs and devices. The Clinton administration and Congress are now
grappling with the serious problem of escalating drug prices in this
country. In these difficult times, academic medicine depends more than
ever on the public's trust and goodwill. If the public begins to
perceive academic medical institutions and clinical researchers as
gaining inappropriately from cozy relations with industry -- relations
that create conflicts of interest and contribute to rising drug prices
-- there will be little sympathy for their difficulties. Academic
institutions and their clinical faculty members must take care not to be
open to the charge that they are for sale.



References


1. Relman AS. Dealing with conflicts of interest. N Engl J Med
1984;310:1182-3.


2. Keller MB, McCullough JP, Klein DN, et al. A comparison of
nefazodone, the cognitive behavioral-analysis system of psychotherapy,
and their combination for the treatment of chronic depression. N Engl J
Med 2000;342:1462-70.


3. Relman AS. New "Information for Authors" -- and readers. N Engl J Med
1990;323:56.


4. Scott J. Treatment of chronic depression. N Engl J Med
2000;342:1518-20.


5. Bodenheimer T. Uneasy alliance -- clinical investigators and the
pharmaceutical industry. N Engl J Med 2000;342:1539-44.


6. Faculty policies on integrity in science. Cambridge, Mass.: Harvard
University, February 1996.


7. Abel D. Harvard mulls easing rules on research. Boston Globe.
February 10, 2000:A1.


8. University and Small Business Patent Procedures Act of 1980.


9. Rothman DJ. Medical professionalism -- focusing on the real issues. N
Engl J Med 2000;342:1284-6.